Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
- Company
- Datascope Corporation
- Recall Initiated
- February 21, 2018
- Posted
- April 16, 2018
- Terminated
- March 18, 2020
- Recall Number
- Z-1384-2018
- Quantity
- 655
- Firm Location
- Fairfield, NJ
Reason for Recall
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
Distribution
US Nationwide Distribution
Lot / Code Info
0684 00 0294 01U and 0684 00 0294 02U
Root Cause
Error in labeling
Action Taken
Maquet/Getinge issued a recall letter on February 21, 2018 to affected customers, via FEDEX with confirmation of delivery, to notify them of the fact that the IFU is missing the Contraindications section and to provide the missing information. Affected customers are instructed to examine their inventory immediately to determine if they have affected product. An Addendum to the Mega IAB Catheter IFU, containing the Contraindications, is provided as an attachment in the recall letter. It is suggested that affected customers post copies of the Addendum near all affected lot numbers of Mega IAB Catheters. Customers are provided with Maquet/Getinge contact information should their facility require a full copy of the correct Mega IAB Catheter IFU. Lastly, affected customers are instructed to complete and sign a response form, acknowledging that they have received the notification, and return the form to Maquet/Getinge.